The Food and Drug Administration has given its approval to the first drug meant to cut a woman’s risk of premature birth.
The agency last week signed off on a synthetic form of progesterone, a hormone normally produced in pregnancy. The drug can be injected into pregnant women who have already experience a surprise preterm birth.
The FDA did require that the drug, known commercially as Makena, be studied further to determine its effectiveness.
Weekly injections of Makena are approved for women carrying one fetus and who do not have other risk factors that could lead to an early delivery.
“It makes tremendous sense that prolonging pregnancy will result in long-term benefits,” said Dr. Alan Fleischman, medical director of the March of Dimes. Fleischman said that every week that gestation periods are prolongs are not born early will almost certainly result in health benefits.
The FDA is asking the drug’s maker, K-V Pharmaceuticals Co., to do more research to show that infants with delayed births because of the drug will have fewer developmental and health problems.
Progsterone treatments have been recommended since 2003 for women with a high-risk of premature births, but without any commercial product on the market, doctors have had to obtain it from compounding pharmacies that make it to order.
“What [the approval] does for both doctors and women is it makes a consistent and high-quality product available,” Fleischman said. “This makes sure women are getting the same drug used in trials.”